The present disclosure generally relates to an administering instrument and a drug solution administering system including the administering instrument and a drug solution administering device.
Syringe pump-type drug solution administering devices are known which administers a drug solution filled in a drug solution container to a living body by a pressing action of a plunger. Further, in administering a drug solution with a drug solution administering device of this type, an administering instrument is sometimes used which includes a puncture part (cannula housing) connected to the drug solution administering device via a predetermined connector and tube.
The puncture part provided in the administering instrument has a contact surface (bottom surface) that comes into contact with a body surface of a user. Further, the puncture part holds a needle tube arranged so as to project from the contact surface. The needle tube held by the puncture part supplies a drug solution fed from the drug solution container via a tube or the like to the living body with the needle tube puncturing the living body.
In the drug solution administering system, the administering instrument is attached to the body surface of the user via the contact surface of the puncture part while the drug solution is administered to the living body. Similarly, the drug solution administering device is attached to the body surface of the user through the contact surface (bottom surface) of the housing in which each member of the drug solution administering device is assembled. Therefore, while the drug solution is administered to the user, the puncture part of the administering instrument and the drug solution administering device are attached to the body surface of the user with the puncture part and the drug solution administering device connected to each other via the tube. For example, when the user moves such as twisting his/her body, the puncture part is pulled toward the drug solution administering device via the tube. Thereby, a force that lifts the puncture part from the body surface acts on the puncture part, which sometimes causes the puncture part to come off the body surface. Further, this possibly causes the needle tube held by the puncture part to come out of the living body.
For example, in a case where the drug solution administering device and the puncture part are attached to a curved body surface (for example, the abdomen, thigh, and so on) or where a thin puncture part is attached to the body surface and then a deviation (difference) in the height direction occurs between a position of the contact surface of the puncture part and a position of the contact surface of the drug solution administering device, a force that lifts the puncture part from the body surface via the tube is likely to act on the puncture part, which increases the possibility that the needle tube is removed from the living body.
An administering instrument is disclosed that is capable of preventing a needle tube from coming out of a living body during administration of a drug solution, and to provide a drug solution administering system including the administering instrument and a drug solution administering device.
In accordance with an aspect, an administering instrument according to the present disclosure is an administering instrument connectable to a drug solution administering device including a drug solution container in which a drug solution is filled. The administering instrument includes a connector that includes a communication part configured to communicate with a lumen of the drug solution container and is connectable to the drug solution administering device; a needle tube configured to puncture a living body; a puncture part including a contact surface that is provided in a lower end and configured to contact a living body surface of the living body, a needle holding part that is provided above the contact surface to hold the needle tube so that a tip of the needle tube projects from the contact surface, and a communication passage communicating with a lumen of the needle tube; and a tube that includes a first end part connected to the puncture part, a second end part connected to the connector, and a tube body communicating from the first end part to the second end part and is configured to supply the drug solution from the lumen of the drug solution container to the needle tube via the communication part of the connector and the communication passage of the puncture part. The tube body has a total length longer than a straight-line distance between the first end part and the second end part.
Further, a drug solution administering system according to the present disclosure includes a drug solution administering device having a drug solution container, a housing that holds the drug solution container, and a plunger configured to push out the drug solution in the drug solution container to the tube.
In accordance with another aspect, a drug solution administering system is disclosed comprising: an administering instrument connectable to a drug solution administering device including a drug solution container in which a drug solution is filled, the administering instrument comprising: a connector that includes a communication part configured to communicate with a lumen of the drug solution container and is connectable to the drug solution administering device; a needle tube configured to puncture a living body; a puncture part including a contact surface that is provided in a lower end and configured to contact a living body surface of the living body, a needle holding part that is provided above the contact surface to hold the needle tube so that a tip of the needle tube projects from the contact surface, and a communication passage communicating with a lumen of the needle tube; a tube that includes a first end part connected to the puncture part, a second end part connected to the connector, and a tube body communicating from the first end part to the second end part, and is configured to supply the drug solution from the lumen of the drug solution container to the needle tube via the communication part of the connector and the communication passage of the puncture part; and wherein the tube body has a total length longer than a straight-line distance between the first end part and the second end part; and the drug solution administering device including the drug solution container, a housing that holds the drug solution container, and a plunger that pushes out the drug solution in the drug solution container to the tube.
According to the administering instrument and the drug solution administering system of the present disclosure, it is possible to prevent the needle tube from coming out of a living body during administration of a drug solution.
Set forth below with reference to the accompanying drawings is a detailed description of embodiments of an administering instrument and a drug solution administering system including the administering instrument and a drug solution administering device and representing examples of the inventive administering instrument and drug solution administering system including the administering instrument, and drug solution administering device disclosed here. The following description does not limit the technical scope described in the claims and the meaning of terms used in the claims. Further, the dimensional ratios in the drawings are exaggerated for convenience of description, and may differ from the actual ratios.
The drug solution administering system 10 may be used to administer a drug solution to a living body. As illustrated in
As illustrated in
The drug solution administering system 10 can continuously administer, for example, a drug solution filled in a drug solution container 110 of the drug solution administering device 100 to a living body over a relatively long period of time (for example, a few minutes to a few hours) by a pressing action of a plunger 130. The drug solution administering system 10 may intermittently administer the drug solution to the living body.
Drug Solution Administering Device
As illustrated in
The drug solution container 110 has a cylindrical body including a lumen 111 in which the drug solution is filled. A tip of the plunger 130 is inserted into the drug solution container 110. A gasket 131 is disposed at the tip of the plunger 130. The gasket 131 can be made of, for example, a rubber material or a resin material such as an elastomer. The outer peripheral portion of the gasket 131 liquid-tightly contacts the inner peripheral surface of the drug solution container 110, which liquid-tightly seals a proximal end side of the gasket 131.
In accordance with an exemplary embodiment, the drug solution container 110, for example, is a so-called pre-filled type drug solution container. The drug solution is therefore filled, in advance, in the lumen 111 of the drug solution container 110. Examples of the drug solution include a protein preparation, a narcotic analgesic, and a diuretic.
A sealing member 113 for preventing leakage of the drug solution is provided in a tip opening (discharge port) of the drug solution container 110. The tip opening of the drug solution container 110 is disposed so as to project to the outside of the housing 120.
The plunger 130 is configured to be movable forward with respect to the drug solution container 110 toward the tip side (left side in
The housing 120 accommodates a battery for supplying power necessary for each operation of the drug solution administering device 100, a substrate to which a controller unit for controlling a motor is attached, a drive mechanism for driving the advancing mechanism, and so on.
The drug solution administering device 100 is configured as a patch type device attached to the body surface (skin) H of the user and used. The housing 120 of the drug solution administering device 100 has, on a contact surface (bottom surface) 121, a sheet-like adhesive part that can be adhered to the body surface. In the initial state before the drug solution administering device 100 is attached to the user, a peelable protective sheet is attached to an adhesive surface of the adhesive part.
Administering Instrument
As illustrated in
As outlined with reference to
As illustrated in
As illustrated in
The first connection part 213 of the communication part 211 is constituted by an insertion hole into which the second end part 242 of the tube 240 is inserted and fixed. The second connection part 214 of the communication part 211 is constituted by a connection needle tube 212 having a needle tip capable of puncturing the sealing member 113. An end on the connector 210 side of the connection needle tube 212 is fixed to the connector 210.
The tube 240 and the lumen 111 of the drug solution container 110 communicate with each other in a state (state illustrated in
As illustrated in
The tube 240 is configured so that a drug solution can be supplied from the lumen 111 of the drug solution container 110 to the needle tube 220 via the communication part 211 of the connector 210 and the communication passage 233 of the puncture part 230. As illustrated in
The “first end part 241” and the “second end part 242” in the present embodiment do not specify the exact positions of the tube 240, but represent a certain range of a part of the tube 240 fixed to (inserted into) the puncture part 230 and a certain range of a part of the tube 240 fixed to (inserted into) the connector 210. Further, the “tube body 243” in the present embodiment means a part of the tube 240 exposed from the puncture part 230 and the connector 210 in the plan view illustrated in
As illustrated in
The “bellows shape” means, in the plan view illustrated in
The length, in the Y-direction, of the curved or bent part (bellows part) of the tube body 243, the number of repetitions of curvature or bending in the direction in which the tube body 243 extends, the position at which the bellows part of the tube body 243 is formed, and so on are not limited, and can be modified suitably.
The length of the tube body 243 means a length of the entirety of the tube 240 stretched to a nearly straight shape (the maximum length of the tube body 243). Further, the straight-line distance d1 between the first end part 241 and the second end part 242 corresponds to a length of the straight line connecting the boundary b1 and the boundary b2.
The tube 240 can be formed to have a total length (length in a state where the first end part 241, the second end part 242, and the tube body 243 are straightened out) of, for example, 20 mm to 200 mm, the first end part 241 of the tube 240 (length of a part inserted into the puncture part 230) can be formed to be, for example, 2 mm to 20 mm, the second end part 242 of the tube 240 (length of a part inserted into the connector 210) can be formed to be, for example, 2 mm to 20 mm, and the tube body 243 of the tube 240 can be formed to have a total length (length in a state where the tube body 243 is straightened out) of, for example, 15 mm to 196 mm. Further, a part with a bellows shape of the tube body 243 can be formed to have a length of, for example, 15 mm to 196 mm in a state where the part is straightened out.
The straight-line distance d1 between the first end part 241 and the second end part 242 can be 10 mm to 150 mm, for example. The total length of the tube body 243, for example, is preferably 1.3 times to 10 times longer than the straight-line distance d1.
The tube 240 can be made of, for example, a hollow member made of resin having flexibility. Examples of the material of the tube 240 can include polyethylene, polypropylene, polybutadiene, polyolefin such as ethylene-propylene copolymer and ethylene-vinyl acetate copolymer, thermoplastic resin such as flexible polyvinyl chloride, various rubbers such as silicone rubber and latex rubber, and various elastomers such as polyurethane elastomer, polyamide elastomer, and polyester elastomer.
As illustrated in
The puncture auxiliary tool 250 is detached from the puncture part 230 after the needle tube 220 punctures the living body. The introducer needle 251 is removed from the lumen of the needle tube 220 when the puncture auxiliary tool 250 is detached from the puncture part 230. As illustrated in
When the introducer needle 251 is removed, in the needle tube 220, the lumen of the needle tube 220 communicates with the communication passage 233 of the puncture part 230. Further, the lumen of the needle tube 220 communicates with the lumen of the tube 240 via the communication passage 233. The administering instrument 200 administers, to the living body, the drug solution fed from the drug solution container 110 of the drug solution administering device 100 via the tube 240 with the needle tube 220 puncturing the living body. In the vicinity of the proximal end (near the upper end) of the communication passage 233, a sealing member 236 is disposed to prevent the leakage of the drug solution from the proximal end of the communication passage 233.
The introducer needle 251 can be a metal needle, for example. Further, the needle tube 220 can be, for example, a tubular member (cannula) made of resin.
The puncture auxiliary tool 250 can be prepared in a state of being attached in advance to the puncture part 230, for example, before the use of the drug solution administering system 10. In the present exemplary embodiment, the needle tube 220 is a double needle that punctures the living body with the introducer needle 251 inserted. For example, instead of a double needle structure, the needle tube 220 may have a structure that enables the living body to be punctured only with the needle tube 220. In the case of a structure that enables the living body to be punctured only with the needle tube 220, the needle tube 220 is preferably configured by a metal needle.
As illustrated in
As illustrated in
As illustrated in
As illustrated in
The puncture part 230 can be formed to have a thickness t1 of 3 mm to 30 mm, for example. Further, the housing 120 can be formed to have a thickness t2 of 10 mm to 30 mm, for example.
As with the drug solution administering device 100, the administering instrument 200 is configured as a patch type instrument adhered to the body surface H of the user and used. The puncture part 230 of the administering instrument 200 has, on a contact surface (bottom surface) 231, a sheet-like adhesive part that can be adhered to the body surface. In the initial state before the administering instrument 200 is attached to the user, a peelable protective sheet is attached to an adhesive surface of the adhesive part.
In a case where the administering instrument 200 punctures the living body with the puncture auxiliary tool 250 attached to the puncture part 230 and the tip of the introducer needle 251 projecting from the tip of the needle tube 220, the contact surface 231 of the puncture part 230 is adhered to the body surface of the user. The puncture auxiliary tool 250 is detached after the needle tube 220 punctures the living body, and the puncture part 230 remains on the body surface H of the user in a state where the needle tube 220 punctures the living body. In this state, the plunger 130 of the drug solution administering device 100 moves forward in the drug solution container 110, which allows the drug solution filled in the lumen 111 of the drug solution container 110 of the drug solution administering device 100 to be fed to the lumen of the needle tube 220 via the communication part 211 of the connector 210, the tube 240, and the communication passage 233 of the puncture part 230.
As described above, the administering instrument 200 according to the present exemplary embodiment includes the connector 210 that includes the communication part 211 capable of communicating with the lumen 111 of the drug solution container 110 and is connectable to the drug solution administering device 100, the needle tube 220 that punctures the living body, the puncture part 230 including the contact surface 231 that is provided in a lower end to contact the body surface H of the living body, the needle holding part 232 that is provided above the contact surface 231 to hold the needle tube 220 so that a tip of the needle tube 220 projects from the contact surface 231, and the communication passage 233 communicating with the lumen of the needle tube 220; and the tube 240 that includes the first end part 241 connected to the puncture part 230, the second end part 242 connected to the connector 210, and the tube body 243 communicating from the first end part 241 to the second end part 242 and is configured to supply the drug solution from the lumen 111 of the drug solution container 110 to the needle tube 220 via the communication part 211 of the connector 210 and the communication passage 233 of the puncture part 230. In accordance with an exemplary embodiment, the tube body 243 has a total length longer than the straight-line distance d1 between the first end part 241 and the second end part 242.
The administering instrument 200 may be disposed in such a manner that, for example, in a state where the puncture part 230 and the housing 120 are attached to the curved body surface H of the user and so on, the position of the contact surface 121 of the housing 120 is higher than the position of the contact surface 231 of the puncture part 230 (the distance away from the body surface H is larger in the former than in the latter). For example, in a case where the puncture part 230 is formed to have a relatively thin shape in consideration of convenience at the use of the administering instrument 200 (such as avoiding the interference of the administering instrument 200 attached to the body surface H), the thickness t1 of the puncture part 230 is smaller than the thickness t2 of the housing 120; therefore, the deviation in the height direction between the contact surface 231 of the puncture part 230 and the contact surface 121 of the housing 120 can be relatively significant. When the user moves such as twisting his/her body, due to the deviation in the height direction at the time of attachment to the body surface H as described above, a force that lifts the puncture part 230 from the drug solution administering device 100 side toward the puncture part 230 acts via the first end part 241 of the tube 240 fixed to the puncture part 230. This force may remove the puncture part 230 from the body surface H and the needle tube 220 held by the puncture part 230 may come out of the living body.
In light of the foregoing issues, in the administering instrument 200 according to the present exemplary embodiment, the tube body 243 has a total length longer than the straight-line distance d1 between the first end part 241 and the second end part 242. In a case where a force acting on the puncture part 230 from the drug solution administering device 100 side via the tube 240 (force that lifts the puncture part 230) is to develop, the tube 240 absorbs (reduces) the force by deforming a part of the tube body 243, which allows the administering instrument 200 to helps prevent the force from being conveyed to the puncture part 230 via the tube 240. Therefore, the administering instrument 200 can suitably prevent the needle tube 220 from coming out of the living body during administration of the drug solution. For example, even in a case where the tube 240 is made of a material having reduced flexibility relative to other resin materials such as polybutadiene, the administering instrument 200 can suitably prevent the needle tube 220 from coming out of the living body during administration of the drug solution.
Further, in the administering instrument 200, at least a part of the tube body 243 extends in a bellows shape, which helps enable the tube body 243 to absorb the force that lifts the puncture part 230 at the part formed in the shape of a bellows.
In accordance with an exemplary embodiment, the drug solution administering system 10 according to the present exemplary embodiment includes the administering instrument 200 and the drug solution administering device 100 that has the drug solution container 110, the housing 120 for holding the drug solution container 110 in the housing 120, the plunger 130 for pushing out the drug solution in the drug solution container 110 to the tube 240. With the use of the drug solution administering system 10, it is possible to absorb the force acting on the puncture part 230 (force that lifts the puncture part 230) at the tube body 243 of the tube 240 during administration of the drug solution. Therefore, the drug solution administering system 10 can suitably prevent the needle tube 220 held by the puncture part 230 from coming out of the living body.
Further, in the drug solution administering system 10, the thickness t1 of the puncture part 230 of the administering instrument 200 is smaller than the thickness t2 of the housing 120 of the drug solution administering device 100. According to the drug solution administering system 10, it is therefore possible to reduce the thickness of the puncture part 230 and suitably prevent the occurrence of a problem that the needle tube 220 held in the puncture part 230 comes out of the living body due to the reduction in thickness of the puncture part 230.
The description goes on to an administering instrument 200A according to the second exemplary embodiment. The same configurations as those in the first embodiment are denoted by the same reference numerals and description of the same reference numerals is omitted. In addition, configurations not particularly mentioned in the second exemplary embodiment can be configured in substantially the same manner as described above in the first exemplary embodiment.
The administering instrument 200 according to the first exemplary embodiment is formed that at least a part of the tube body 243 of the tube 240 extends in a bellows shape (see
The tube body 343 has a total length longer than a straight-line distance d1 between a first end part 341 and a second end part 342.
The “spiral” shape according to the present embodiment means a shape of the tube 340 that winds three-dimensionally around an axis of the tube 340 straightened out. In other words, the tube 340 has a shape in which at least a part of the tube body 343 is bent in a spiral shape in the X-Y-Z direction.
The length of the spiral part of the tube body 343, the number of repetitions of spiral in the direction in which the tube body 343 extends, the position at which the spiral part of the tube body 343 is formed, and so on are not limited, and can be modified suitably.
The length of the tube body 343 means a length of the entirety of the tube 340 stretched to a nearly straight shape (the maximum length of the tube body 343). Further, the straight-line distance d1 between the first end part 341 and the second end part 342 corresponds to, as illustrated in
The tube 340 can be formed to have a total length (length in a state where the first end part 341, the second end part 342, and the tube body 343 are straightened out) of, for example, 20 mm to 200 mm, the first end part 341 of the tube 340 (length of a part inserted into the puncture part 230) can be formed to be, for example, 2 mm to 20 mm, the second end part 342 of the tube 340 (length of a part inserted into the connector 210) can be formed to be, for example, 2 mm to 20 mm, and the tube body 343 of the tube 340 can be formed to have a total length (length in a state where the tube body 343 is straightened out) of, for example, 15 mm to 196 mm. Further, a part with a spiral shape of the tube body 343 can be formed to have a length of, for example, 15 mm to 195 mm in a state where the part is straightened out.
The straight-line distance d1 between the first end part 341 and the second end part 342 can be 10 mm to 150 mm, for example. The total length of the tube body 343 is preferably 1.3 to 10 times longer than the straight-line distance d1.
As described above, in the administering instrument 200A according to the present exemplary embodiment, at least a part of the tube body 343 of the tube 340 extends in a spiral shape. Therefore, in the administering instrument 200A, as with the administering instrument 200 according to the first exemplary embodiment, in a case where a force acting on the puncture part 230 from the drug solution administering device 100 side via the tube 340 (force that lifts the puncture part 230) is to develop, a part of the tube body 343 deforms to absorb (reduce) the force. Thus, the administering instrument 200A can suitably prevent the needle tube 220 from coming out of the living body during administration of the drug solution.
Further, since at least a part of the tube body 343 of the tube 340 has a spiral shape, in a case where a force that lifts the puncture part 230 is to develop, the tube body 343 deforms three-dimensionally to absorb the force, which further helps prevent the puncture part 230 from being lifted. Further, since at least a part of the tube body 343 flexes to have a three-dimensional spiral shape, even in a case where the tube body 343 has an elongated part that absorbs the force, it is possible to help prevent the long distance between the first end part 341 and the second end part 342 from becoming excessively long. Thus, the administering instrument 200A can be made more compact.
The administering instrument and the drug solution administering system according to the embodiments of the present disclosure are describe above. The present disclosure is not limited only to the configurations described above, and can be modified suitably on the basis of the description of claims.
For example, the tube body may both have the bellows shape described in the first exemplary embodiment and the spiral shape described in the second exemplary embodiment. Further, the shape of the tube body is not particularly limited as long as the tube body has a total length longer than the straight-line distance between the first end part and the second end part to absorb (reduce) the force that lifts the puncture part. In addition, the tube body can be configured to have, for example, a shape other than the bellows or spiral shape.
In addition, the material, shape, size, and arrangement of the members constituting the administering instrument and the drug solution administering system, and the connecting/coupling structures of the members of the administering instrument and the drug solution administering system are not particularly limited as long as the effects of the present disclosure are exhibited, and can be changed and replaced as desired. Moreover, it is also possible to appropriately add any members or the like, which are not particularly described in the specification, to the administering instrument and the drug solution administering system.
The detailed description above describes embodiments of an administering instrument and a drug solution administering system including the administering instrument and a drug solution administering device. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
Number | Date | Country | Kind |
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2018-067426 | Mar 2018 | JP | national |
This application is a continuation of International Application No. PCT/JP2019/013309 filed on Mar. 27, 2019, which claims priority to Japanese Patent Application No. 2018-067426 filed on Mar. 30, 2018, the entire content of both of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2019/013309 | Mar 2019 | US |
Child | 17038681 | US |